search
Back to results

The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal
Moisturizer containing Colloidal Oatmeal only
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, skin, dermatology, isosorbide diesters, skin microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18 or over
  • Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.

Exclusion Criteria:

  • Individuals who have a known allergy to isosorbide diesters.
  • Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body.
  • Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period.
  • Subjects with an ongoing secondary infection of the skin.
  • Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period.
  • Subjects with a diagnosis of Scabies.
  • Pregnant women
  • Prisoners

Sites / Locations

  • Integrative Skin Science and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Moisturizer containing colloidal oatmeal

Arm Description

Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.

Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily

Outcomes

Primary Outcome Measures

EASI75
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.

Secondary Outcome Measures

Change in EASI score
Eczema severity is assessed using the Eczema Area and Severity Index.
Change in EASI score
Eczema severity is assessed using the Eczema Area and Severity Index.
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Change in relative abundance of S. aureus
Skin microbiome related measurement of S. aureus relative abundance

Full Information

First Posted
April 1, 2021
Last Updated
November 5, 2022
Sponsor
Integrative Skin Science and Research
Collaborators
Sytheon Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04831892
Brief Title
The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
Official Title
The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Sytheon Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.
Detailed Description
The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, skin, dermatology, isosorbide diesters, skin microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal
Arm Type
Experimental
Arm Description
Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.
Arm Title
Moisturizer containing colloidal oatmeal
Arm Type
Active Comparator
Arm Description
Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily
Intervention Type
Other
Intervention Name(s)
Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal
Intervention Description
Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)
Intervention Type
Other
Intervention Name(s)
Moisturizer containing Colloidal Oatmeal only
Intervention Description
Vehicle lotion containing 0.1% colloidal oatmeal.
Primary Outcome Measure Information:
Title
EASI75
Description
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Time Frame
Week 4
Title
Change in IVAS
Description
Itch severity is assessed using the Itch Visual Analog Scale.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in EASI score
Description
Eczema severity is assessed using the Eczema Area and Severity Index.
Time Frame
Week 1
Title
Change in EASI score
Description
Eczema severity is assessed using the Eczema Area and Severity Index.
Time Frame
Week 5
Title
Change in IVAS
Description
Itch severity is assessed using the Itch Visual Analog Scale.
Time Frame
Week 1
Title
Change in IVAS
Description
Itch severity is assessed using the Itch Visual Analog Scale.
Time Frame
Week 5
Title
Change in TEWL
Description
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time Frame
Week 1
Title
Change in TEWL
Description
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time Frame
Week 4
Title
Change in TEWL
Description
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time Frame
Week 5
Title
Change in skin hydration level
Description
Skin hydration levels are measured using a moisture meter.
Time Frame
Week 1
Title
Change in skin hydration level
Description
Skin hydration levels are measured using a moisture meter.
Time Frame
Week 4
Title
Change in skin hydration level
Description
Skin hydration levels are measured using a moisture meter.
Time Frame
Week 5
Title
Change in DLQI survey responses
Description
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time Frame
Week 1
Title
Change in DLQI survey responses
Description
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time Frame
Week 4
Title
Change in DLQI survey responses
Description
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time Frame
Week 5
Title
Change in relative abundance of S. aureus
Description
Skin microbiome related measurement of S. aureus relative abundance
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 or over Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50. Exclusion Criteria: Individuals who have a known allergy to isosorbide diesters. Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body. Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period. Subjects with an ongoing secondary infection of the skin. Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects with a diagnosis of Scabies. Pregnant women Prisoners
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

We'll reach out to this number within 24 hrs